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AXS-05 for Depression

Phase 4
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current major depressive episode of at least 4 weeks in duration
Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
Must not have
Received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights

Summary

This trial is being conducted to see if a new medication called AXS-05 is effective in preventing the return of depressive symptoms in people with major depressive disorder. The study will compare AXS-05

Who is the study for?
This trial is for individuals currently diagnosed with Major Depressive Disorder (MDD) without psychotic features, experiencing a depressive episode lasting at least 4 weeks. It's not open to those who've been in AXS-05 studies before, used investigational drugs or Auvelity within the last month, or can't follow study procedures.Check my eligibility
What is being tested?
The study tests if AXS-05 is better than Bupropion at preventing relapse of depression in people whose symptoms improved after taking AXS-05. Participants are randomly assigned to either drug and won't know which one they're getting during the trial.See study design
What are the potential side effects?
Potential side effects for both AXS-05 and Bupropion may include nausea, headache, dry mouth, dizziness, insomnia or anxiety. The exact side effects will vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing a major depressive episode for at least 4 weeks.
Select...
I have been diagnosed with major depression without experiencing psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken any experimental drugs or used experimental devices in the last 30 days, nor have I been prescribed Auvelity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to relapse of depressive symptoms

Side effects data

From 2019 Phase 3 trial • 327 Patients • NCT04019704
29%
All Others, occurring in <5% of Subjects
16%
Dizziness
13%
Nausea
8%
Headache
7%
Somnolence
7%
Diarrhea
6%
Dry mouth
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AXS-05

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AXS-05Experimental Treatment1 Intervention
AXS-05 tablets, taken twice daily
Group II: BupropionActive Control1 Intervention
Bupropion tablets, taken twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2018
Completed Phase 3
~1390

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include SSRIs, SNRIs, and newer agents like AXS-05. SSRIs (Selective Serotonin Reuptake Inhibitors) increase serotonin levels in the brain by inhibiting its reuptake, which helps improve mood and emotional stability. SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) work similarly but also increase norepinephrine levels, providing additional benefits for energy and alertness. AXS-05, a newer treatment, combines dextromethorphan and bupropion, acting as an NMDA receptor antagonist, sigma-1 receptor agonist, and norepinephrine-dopamine reuptake inhibitor. This combination targets multiple pathways involved in mood regulation, potentially offering more comprehensive symptom relief. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment based on individual symptoms and treatment response.
Consistently Modest Antidepressant Effects in Clinical Trials: the Role of Regulatory Requirements.Strategies to achieve clinical effectiveness: refining existing therapies and pursuing emerging targets.

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
30 Previous Clinical Trials
10,057 Total Patients Enrolled
8 Trials studying Depression
2,454 Patients Enrolled for Depression
~233 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
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